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SecurAcath Versus Statlock for PICC Securement

NCT ID: NCT02311127

Last Updated: 2015-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-12-31

Brief Summary

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Peripherally inserted central catheters (PICCs ) are used for the administration of intravenous fluids and for blood sampling. PICCs may remain in place for weeks to months and are safeguarded from migration or accidental dislodgement by securement devices. Different types of these devices are available. StatLock® (C.R. Bard) is a stabilization device with an adhesive anchor pad. The catheter wings of the PICC must be placed over the posts then the system is closed with "gull-wings" . StatLock® has to be changed weekly. Healthcare providers have to pay attention to prevent accidental catheter dislodgement during the renewal procedure. SecurAcath® (Interrad Medical) is a new securement device to the European market. The device uses a small subcutaneous anchor to secure the PICC. One of the advantages compared to adhesive stabilization devices, is a reduction in maintenance time by simplifying dressing changes and subsequently staff time. It is described that nurses report that care is left undone due to low staffing levels. Therefore, investigation of nursing time savings with the support of technology is imperative. SecurAcath® remains in place for life of the PICC and therefore has the potential to reduce the time for dressing change as there is no need for weekly device change. The objective of this study is to measure nursing time for dressing change and explore inserting and removal issues and patient experiences.

Detailed Description

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Conditions

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Patients With Any Condition Who Need a PICC for IV Therapy

Keywords

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Peripherally Inserted Central Catheters Securement device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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SecurAcath

Subcutaneous securement

Group Type EXPERIMENTAL

SecurAcath

Intervention Type DEVICE

Devices secures PICC subcutaneously and remains in place during the complete dwell time of the PICC

StatLock

Adhesive securement

Group Type ACTIVE_COMPARATOR

StatLock

Intervention Type DEVICE

Device secures PICC however, device has to be changed weekly

Interventions

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SecurAcath

Devices secures PICC subcutaneously and remains in place during the complete dwell time of the PICC

Intervention Type DEVICE

StatLock

Device secures PICC however, device has to be changed weekly

Intervention Type DEVICE

Other Intervention Names

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Subcutaneous catheter securement system Sutureless adhesive-backed device

Eligibility Criteria

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Inclusion Criteria

* Polyurethane PICC insertion
* Dutch speaking patient, able to give informed consent
* Intravenous treatment is administered in the University Hospitals Leuven

Exclusion Criteria

* patients with known allergy to nickel or ethylene oxide
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Godelieve A Goossens, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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University Hospitals Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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Egan GM, Siskin GP, Weinmann R 4th, Galloway MM. A prospective postmarket study to evaluate the safety and efficacy of a new peripherally inserted central catheter stabilization system. J Infus Nurs. 2013 May-Jun;36(3):181-8. doi: 10.1097/NAN.0b013e3182893690.

Reference Type BACKGROUND
PMID: 23558917 (View on PubMed)

Elen Hughes M. Reducing PICC migrations and improving patient outcomes. Br J Nurs. 2014 Jan 23-Feb 12;23(2):S12, S14-8. doi: 10.12968/bjon.2014.23.sup1.s12.

Reference Type BACKGROUND
PMID: 24464053 (View on PubMed)

Alekseyev S, Byrne M, Carpenter A, Franker C, Kidd C, Hulton L. Prolonging the life of a patient's IV: an integrative review of intravenous securement devices. Medsurg Nurs. 2012 Sep-Oct;21(5):285-92.

Reference Type BACKGROUND
PMID: 23243786 (View on PubMed)

Goossens GA, Grumiaux N, Janssens C, Jerome M, Fieuws S, Moons P, Stas M, Maleux G. SecurAstaP trial: securement with SecurAcath versus StatLock for peripherally inserted central catheters, a randomised open trial. BMJ Open. 2018 Feb 24;8(2):e016058. doi: 10.1136/bmjopen-2017-016058.

Reference Type DERIVED
PMID: 29478011 (View on PubMed)

Other Identifiers

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S57358

Identifier Type: -

Identifier Source: org_study_id